Anti-thrombotic Monotherapy in HeartMate 3 Left Ventricular Assist System (LVAS)

Institute for Clinical and Experimental Medicine

Status

Unknown

Conditions

Cardiovascular Diseases

Heart Failure

Treatments

Drug: Warfarin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03781258

Version 1.0

Details and patient eligibility

About

The purpose of this prospective controlled study is to obtain a multi-center safety and feasibility data on patients managed with anti-thrombotic monotherapy with HeartMate 3 LVAS.

Full description

Patients implanted with the HeartMate 3 LVAS will be screened for participation in the study with established stability at 6 months after implantation of the device. If inclusion criteria are met, patients will be transitioned to a single anti-thrombotic therapy with Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy and anticoagulation with warfarin will be withdrawn. ASA will be administered in a minimum dose of 100 mg per day with dosage adjustments based on VerifyNow testing up to a maximum of 200 mg daily. The primary endpoints will be analyzed at 90 and 180 days after initiation of the single antiplatelet therapy.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients implanted with HeartMate 3 LVAS irrespective of intended goal of treatment of bridge to transplant or destination therapy
a minimum of 6 months since HeartMate3 LVAS implantation free of thromboembolic events and pump malfunction
evidence of forward flow across the aortic valve (with aortic valve opening of at least 1:2 per cardiac cycle) at baseline echocardiography (ECHO) or after speed reduction as long as no evidence of progression of heart failure is noted, based on a combination of biomarkers and clinical assessment follow-up (see Appendix III); Clinical assessment will include review of the biomarkers, invasive or non-invasive hemodynamics (as available or indicated) and clinical physical examination

Exclusion criteria

absence of an informed consent
presence of any prosthetic valve or central aortic valve repair (e.g. Park's stitch)
presence of any other ancillary circulatory assist device system
known history of major thrombotic event e.g. deep vein thrombosis (DVT)
known history of stroke
left atrial appendage in patients with atrial fibrillation or flutter not addressed by resection or exclusion at a time of the implant
evidence of any intracardiac thrombus evidenced by transoesophageal echocardiography
any other clinical indication for a use of long-term anticoagulation using a vitamin K antagonist or thrombin inhibitor (e.g. specified known genetic thrombotic mutation mandating the therapy, malignancy)